FDA Adverse Event Malfunction Summary report: N

D-SPECT® CARDIO

MDR report key: 19360541 · Received May 21, 2024

Report

Report Number
19360541
Event Type
Malfunction
Date Received
May 21, 2024
Date of Event
February 16, 2024
Report Date
April 29, 2024
Manufacturer
SPECTRUM DYNAMICS MEDICAL, INC
Product Code
KPS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

SUMMARY: A PATIENT WITH LEFT SIDED HEMIPARESIS AND NO TRUNK CONTROL WAS AT THE CLINIC FOR A NUCLEAR STRESS TEST. THE PATIENT WAS SUCCESSFULLY TRANSFERRED TO THE CAMERA BY MULTIPLE STAFF. AT THE CONCLUSION OF TESTING, THE TECHNICIAN TURNED AWAY FROM THE PATIENT TO VIEW COMPUTER TO CONFIRM QUALITY OF IMAGES. DURING THIS TIME THE PATIENT¿S LEFT UPPER TORSO FELL FROM THE CAMERA TO THE FLOOR WITHIN THE OPEN SPACE OF THE CAMERA. THE PATIENT REPORTED NO PAIN AND DECLINED BEING SEEN BY A PROVIDER. DAYS LATER, THE PATIENT¿S WIFE CALLED STATING THAT THE PATIENT WAS BRUISED, AND THAT PAIN HAD DEVELOPED. IT WAS IDENTIFIED THAT THE PATIENT HAD A CLOSED DISPLACED LEFT CLAVICLE FRACTURE, MULTIPLE CLOSED RIB FRACTURES, AND BRUISING LEFT TORSO. PATIENT CANCELED SCHEDULED SURGERY PROCEDURE DUE TO PAIN FROM INJURIES. PROBLEM: THE CAMERA DID NOT COME WITH ANY SECUREMENT DEVICES THAT COULD BE USED FOR PATIENTS WITH LIMITED ABILITY TO PARTICIPATE IN THEIR CARE. WE REACHED OUT TO THE MANUFACTURER TO ASK WHETHER THEY HAVE ANYTHING THAT COULD BE USED TO SECURE THE PATIENT TO THE CHAIR AND THEY STATED THAT THEY DO SELL NARROW STRAPS THAT CAN BE USED AND REFERRED US TO THE SALES MANAGER. THE SALES MANAGER INDICATED THAT THEY HAVE CHEST STRAPS AND LEG STRAPS AVAILABLE. WHEN WE REQUESTED ADDITIONAL INFORMATION (PICTURES AND SPECIFICATIONS OF THE STRAPS), THE SALES MANAGER STATED THAT THERE ARE STRAPS THAT ARE NOW PART OF THE STANDARD CONFIGURATION AND THAT THEY WERE SENT TO ANOTHER LOCATION THAT IS PART OF OUR HEALTH SYSTEM IN OUR LAST ORDER. WE REQUESTED A NEW MANUAL TO ENSURE APPROPRIATE USE, TRAINING, INFECTION PREVENTION PRACTICES ETC., AND THE SALES MANAGER STATED THAT THEY DO NOT HAVE AN UPDATED MANUAL WITH THE STRAPS IN IT. THE LAST COMMUNICATION WITH THE MANUFACTURER IS THAT THEY ARE LOOKING FOR DOCUMENTATION ON THE STRAPS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1155377 D-SPECT® CARDIO SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS SPECTRUM DYNAMICS MEDICAL, INC 004

Patients

Seq Age Sex Outcome Treatment
1 75 YR Male Other